Melanoma Clinical Trial
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
Full Description
This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.
The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent prior to initiation of any study-specific procedures.
Metastatic or advanced stage solid tumor
Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.
Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
ECOG performance status 0-1
Adequate organ function, as measured by laboratory values (criteria listed in protocol).
Able to swallow, retain, and absorb oral medications.
Exclusion Criteria:
Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria)
In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
Active, uncontrolled bacterial, fungal, or viral infection.
Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded
Women who are lactating or breastfeeding, or pregnant.
Participants with any other active treated malignancy within 3 years prior to enrollment
Complete inclusion and exclusion criteria are listed in the clinical study protocol.
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There are 34 Locations for this study
Duarte California, 91010, United States
Fullerton California, 92835, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States More Info
Principal Investigator
Sacramento California, 95817, United States
Santa Rosa California, 95403, United States
Stanford California, 94305, United States More Info
Principal Investigator
Orlando Florida, 32806, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
Decatur Illinois, 62526, United States
Bethesda Maryland, 20817, United States
New York New York, 10016, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Cleveland Ohio, 44195, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19114, United States
Tacoma Washington, 98405, United States
Wollstonecraft New South Wales, 2065, Australia
Wuhan Hubei, 43002, China
Linyi Shandong, 27600, China
Beijing , 10014, China
Shanghai , 20043, China
Cheongju-si , 28644, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam , , Netherlands
Barcelona , 08035, Spain More Info
Principal Investigator
Barcelona , , Spain More Info
Principal Investigator
Las Palmas De Gran Canaria , , Spain More Info
Principal Investigator
Madrid , 29009, Spain More Info
Principal Investigator
Valencia , , Spain More Info
Principal Investigator
Taipei , 11217, Taiwan
Taipei , , Taiwan
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